Radiation Protection Legislation Brief Introduction Relevant Legislation I

Radiation Protection Legislation Brief Introduction

Relevant Legislation I n n Ionising Radiations Regulations 1999 Ionising Radiation (Medical Exposure) Regulations 2000 – Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006 – Ionising Radiation (Medical Exposure) (Amendment) Regulations 2011 n Medicines (Administration of Radioactive Substances) Regulations 1978 – Medicines (Administration of Radioactive Substances) amendment Regulations 2006

Relevant Legislation II n n n Environmental Permitting Regulations 2010 Environmental Permitting (Amendment) Regulations 2011 Carriage of Dangerous Goods and Use of Pressurised Vessel Regulations 2009 – The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) Regulations 2011 n The Human Medicines Regulations 2012

Rules, Rules Ÿ ICRP 60 (1991) Ÿ EC Directive Ÿ (96/29/Euratom = Basic Safety Directive Ÿ (97/43/Euratom) = Medical Exposures Directive Ÿ IRR 99 Ÿ IR(ME)R 2000 • implemented 13 May 2000 • amended: 01 November 2006 25 July 2011

Ionising Radiations Regulations 1999 41 regulations, 9 schedules n General legislation (all industries) n – Protect at a place of work – Safety of medical equipment n Enforced by Health & Safety Executive (HSE)

IRR 99 Supporting documents n Medical and Dental Guidance Notes (A good practice guide on all aspects of ionising radiation protection in the clinical environment) (IPEM) – Guidance relating specifically to medical radiation use n Approved Code of Practice and Guidance (“L 121”) (HSE) – Acceptable means of compliance with the regulations

Ionising Radiation (Medical Exposure) Regulations 2000 (& Amendments 2006 & 2011) n n 14 Regulations, 2 schedules Apply to: – Radiation exposures of patients as part of diagnosis or treatment (asymptomatics) – Radiation exposures of volunteers for research – Radiation exposures for medico-legal purposes – Radiation exposures as part of occupational health monitoring

IR(ME)R Require: Medical radiation exposures to be justified n radiation doses to be appropriate n People delivering exposures to be properly trained n n Enforced by Care Quality Commission (CQC)

IR(ME)R Supporting documents n Notes on good practice (Available via internet only)

MARS Medicines (Administration of Radioactive Substances) Regulations 1978 Administration of radiopharmaceuticals n Diagnosis & Therapy n Manufacturing n Dispensing n Pharmacist must be involved n (directly supervise) n Enforced by Medicines & Healthcare Products Regulatory Agency (MHRA)

MARS Medicines (Administration of Radioactive Substances) Regulations 1978 Links to IR(ME)R n ARSAC Administration of Radioactive Substances Advisory Committee n The Human Medicines Regulations 2012 – Requires IRMER Practitioner to be an ARSAC Certificate holder

EPR 2010 Environmental Permitting Regulations 2010 n n n General Legislation (all industries) Permits for all disposals (including radioactive substances) No change to current – Registrations (keep & use) – Authorisations (accumulate & dispose) n Radioactive Waste Adviser – Competence recognition scheme n Replaced HASS 2005 n Enforced by Environment Agency (EA)

EPAR 2011 Environmental Permitting (Amendment) Regulations 2011 n n Removes last vestiges of Radioactive Substances Act 1993 (RSA 93) Replaces all legacy Exemption Orders from RSA 1960 & 1993 Except in Northern Ireland

Carriage of Dangerous Goods and Use of Pressurised Vessel Regulations 2009 General Legislation (all industries) n Linked to European “ADR” Regulations Accord Dangereux Routier n Special packaging n Consignment & Receipt n Need DGSA for regular shipments n Enforced by Office for Nuclear Safety n The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) Regulations 2011